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Deliberate hypotension with propofol under anaesthesia for functional endoscopic sinus surgery (FESS)

  1. Suhattaya Boonmak1,*,
  2. Polpun Boonmak1,
  3. Malinee Laopaiboon2

Editorial Group: Cochrane Anaesthesia, Critical and Emergency Care Group

Published Online: 6 JUN 2013

Assessed as up-to-date: 17 APR 2012

DOI: 10.1002/14651858.CD006623.pub2


How to Cite

Boonmak S, Boonmak P, Laopaiboon M. Deliberate hypotension with propofol under anaesthesia for functional endoscopic sinus surgery (FESS). Cochrane Database of Systematic Reviews 2013, Issue 6. Art. No.: CD006623. DOI: 10.1002/14651858.CD006623.pub2.

Author Information

  1. 1

    Khon Kaen University, Department of Anaesthesiology, Faculty of Medicine, Khon Kaen, Thailand

  2. 2

    Khon Kaen University, Department of Biostatistics and Demography, Faculty of Public Health, Khon Kaen, Thailand

*Suhattaya Boonmak, Department of Anaesthesiology, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002, Thailand. suhattayab@hotmail.com. suhattaya@gmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 6 JUN 2013

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Characteristics of included studies [ordered by study ID]
Eberhart 2003

MethodsRandomization and treatment allocation method: yes.
Blinding of outcome assessment: yes.
Blinding of participants: yes.

Duration: not stated.


ParticipantsNumber: 88 participants (45 participants in propofol group vs 43 in isoflurane group).

Inclusion criteria: ASA grade I-II undergoing endoscopic surgery for chronic sinusitis.

Exclusion criteria: not stated.


Interventions
  • Propofol group (propofol and remifentanil continuous infusion keeping MAP between 60 and 70 mm Hg).
  • Isoflurane group (isoflurane and alfentanil keeping MAP between 60 and 70 mm Hg).


Outcomes
  • Blood loss (volume of suctioned blood).
  • Surgical conditions and dryness of the operation site (10-cm visual analogue scale and 6-point scale surgical field).
  • Adverse events.
  • Operation time.
  • Failure deliberate hypotension.


NotesAdditional information from Dr. LH Eberhart.

Location: Germany.

Setting: operating room.

Source of funding: not stated.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment.

Allocation concealment (selection bias)Low riskQuote: "With the use of sealed envelopes the patients were allocated to one of the following two groups immediately before start of anesthesia."

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "Several measures were made to keep the surgeon and the instrumenting nurse blind to the type of anesthesia. Isoflurane vapour and the display of end-tidal isoflurane concentrations on the anesthesia machine were covered. Perfusion syringes containing propofol and remifentanil were connected to each patient but were also covered."

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data.

Selective reporting (reporting bias)Low riskAuthors reported all pre-specified outcomes.

Ragab 2010

MethodsRandomization and treatment allocation method: yes.
Blinding of outcome assessment: yes.
Blinding of participants: yes.

Duration: not stated.


ParticipantsNumber: 70 participants (35 participants in propofol/remifentanil group vs 35 in isoflurane/fentanyl/esmolol group).

Inclusion criteria: children undergoing endoscopic surgery for chronic sinusitis after failed maximal medical therapy after maxillary sinus aspirate or middle meatal culture and adenoidectomy.

Exclusion criteria: immunodeficiency, ciliary dyskinesia, cystic fibrosis, significant psychological problems, inability to comply with study protocol, systemic diseases affecting the nose, systemic diseases preventing participation in the study and medical and/or surgical treatments influencing the study.


Interventions
  • Propofol group (propofol and remifentanil continuous infusion keeping MAP 50 mm Hg).
  • Isoflurane group (isoflurane, fentanyl and esmolol keeping MAP 50 mm Hg).


Outcomes
  • Blood loss (volume of suctioned blood).
  • Surgical conditions and dryness of the operation site (10-cm visual analogue scale and 6-point scale surgical field).
  • Operative time.
  • Heart rate and blood pressure.
  • Adverse events.


NotesLocation: Egypt.
Setting: operating room in general hospital.
Source of funding: not stated.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote:"In order to maintain exactly equal treatment numbers in both groups, randomization was done using random blocks."

Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement.

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote:"At the time of randomization, neither the patients nor the investigators were aware of the group assignment."

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data.

Selective reporting (reporting bias)Low riskAuthors reported all pre-specified outcomes.

Tirelli 2004

MethodsRandomization and treatment allocation method: unclear.
Blinding of outcome assessment: yes.
Blinding of participants: yes.

Duration: not stated.


ParticipantsNumber: 64 participants (37 in isoflurane group vs 27 in propofol group).

Inclusion criteria: participants who were undergoing endoscopic sinus surgery with ASA physical status I-II.

Exclusion criteria: not stated.


Interventions
  • Propofol group (propofol infusion with remifentanil).
  • Isoflurane group (isoflurane and fentanyl).


All participants were pre-medicated with atropine and midazolam. Keep MAP between 60 and 70 mm Hg.


Outcomes
  • Surgical field grade.
  • Haemodynamic values during operation.


NotesLocation: Italy.

Setting: operating room.

Source of funding: not stated.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information to permit judgment.

Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgment.

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "... the surgeon, unaware of the drug used, evaluated the quality of the surgical field."

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data.

Selective reporting (reporting bias)Low riskAuthors reported all pre-specified outcomes.

Wormald 2005

MethodsRandomization and treatment allocation method: unclear.
Blinding of outcome assessment: no.
Blinding of participants: yes.

Duration: not stated.


ParticipantsNumber: 56 participants (28 in sevoflurane group vs 28 in propofol group).

Inclusion criteria: participants over 18 years of age undergoing endoscopic sinus surgery with ASA physical status I-II.

Exclusion criteria: participants receiving cardiovascular active drug and drug influencing blood coagulation.


Interventions
  • Sevoflurane group (maintained with sevoflurane 0.8% to 1.8% and bolus doses of fentanyl up to 7 mcg/kg).
  • Propofol group (target-controlled infusion 2 to 4 mcg/mL and remifentanil infusion 0.2 to 0.3 mcg/kg/min).


In both groups maintained MAP between 55 and 70 mm Hg, pulse rate < 60 beats/min. Metoprolol (0.07 mg/kg) and clonidine (1 to 2 mg/kg) were added to control.


Outcomes
  • Surgical grade (6-point scale surgical field).
  • Surgical operating time.
  • MAP, HR.


NotesLocation: Australia.

Setting: operating room.

Source of funding: not stated.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "...randomly assigned to each arm using a random number allocation method."

Allocation concealment (selection bias)Unclear riskInsufficient information to permit judgement.

Blinding (performance bias and detection bias)
All outcomes
Low riskQuote: "Although it was not possible to blind the surgeon to the type of anesthesia, the surgeon made a conscious effort not to try to ascertain which type of anesthesia was administered. In most cases the syringe drivers for the propofol infusion were set up and present even when the patient was receiving inhalational anesthesia."

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo missing data.

Selective reporting (reporting bias)Low riskAuthors reported all pre-specified outcomes.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Ahn 2008Study group and control group did not receive deliberate hypotension.

Ankichetty 2012Study group and control group did not receive deliberate hypotension.

Beule 2007Study group and control group did not receive deliberate hypotension.

Pavlin 1999Study group and control group did not receive deliberate hypotension.

Sivaci 2004Study group and control group did not receive deliberate hypotension.

 
Characteristics of ongoing studies [ordered by study ID]
Gomez-rivera 2011

Trial name or titleEffects of total intravenous anesthesia vs inhalational anesthesia in endoscopic sinus surgery for chronic rhinosinusitis: a randomized controlled study.

MethodsRandomization and treatment allocation method: yes.
Blinding of outcome assessment: yes.
Blinding of participants: yes.

ParticipantsParticipants undergoing endoscopic sinus surgery for chronic rhinosinusitis.

InterventionsCompare between anaesthesia with sevoflurane/remifentanil and total intravenous anaesthesia with propofol/remifentanil.

OutcomesPrimary outcome: bleeding, surgical field visualization, assessment of platelet function, assessment of nasal blood flow to the sinonasal mucosa.
Secondary outcome: comparison of operative time, comparison of quality of recovery.

Starting dateMay 2010.

Contact informationFernando Gomez-Rivera (Memorial Hermann Hospital-Medical Center, Houston, TX 77030, United States).

Notes

 
Comparison 1. Propofol versus inhalation anaesthetics

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Quality of surgical field (age group)4277Mean Difference (IV, Random, 95% CI)-0.64 [-0.91, -0.37]

    1.1 Adult
3207Mean Difference (IV, Random, 95% CI)-0.75 [-1.10, -0.40]

    1.2 Children
170Mean Difference (IV, Random, 95% CI)-0.40 [-0.64, -0.16]

 2 Operation time (minutes)3214Mean Difference (IV, Fixed, 95% CI)-4.81 [-11.82, 2.21]

    2.1 Adult
2144Mean Difference (IV, Fixed, 95% CI)3.89 [-9.64, 17.42]

    2.2 Children
170Mean Difference (IV, Fixed, 95% CI)-8.0 [-16.20, 0.20]

 
Summary of findings for the main comparison. Propofol versus inhalation anaesthetics for functional endoscopic sinus surgery (FESS)

Propofol compared with inhalation anaesthetics for functional endoscopic sinus surgery (FESS)

Patient or population: participants with functional endoscopic sinus surgery (FESS).
Settings: deliberate hypotension during general anaesthesia.
Intervention: propofol versus inhalation anaesthetics.

OutcomesIllustrative comparative risks* (95% CI)No. of Participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

Inhalation agentsPropofol

Total blood loss (millilitres)ChildrenMean 120 millilitresMean difference -20.00 millilitres (-39.23 to -0.77)70 (1)⊕⊝⊝⊝
Low
One study only and both random sequence generation and allocation concealment status were unclear.

Quality of surgical field (0-5 scales)Mean 2.55 scaleMean difference -0.64 scale (-0.91 to -0.37)277 (4)⊕⊕⊝⊝
Low
Three studies had unclear random sequence generation. Three studies had unclear allocation concealment.

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval.

GRADE Working Group grades of evidence:
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.